PMA P950029S128
- Device
- Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S128
- Product code
- DXY
- Decision date
- 2020-10-20
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Alternate equipment to be used for microelectronic and Surface Mount Technology assembly.
Current openFDA PMA Record#
- Device
- Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S128
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-10-20
- Decision code
- OK30
- Date received
- 2020-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate equipment to be used for microelectronic and Surface Mount Technology assembly.